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Completed

NCT Number: NCT01603641

BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity

This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric lower limb spasticity.

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Key information

Conditions

Pediatrics Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Semmelweis Egyetem- Ortopédiai Klinika Karolina út 27, Budapest, Hungary

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Minimum weight of 10 kilograms (kg)/22 pounds (lb)
  • Cerebral palsy with dynamic muscle contracture of the ankle

Exclusion criteria

  • Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or mitochondrial disease
  • Uncontrolled epilepsy
  • Botulinum Toxin therapy of any serotype for any condition within the last 3 months
  • History of surgical intervention of the lower study leg within 1 year, or planned surgery of any limb during the study

Treatment and study plan

Botulinum toxin type A

Biological

Participants received intramuscular injections of botulinum toxin Type A into the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments.

Other names: BOTOX®, OnabotulinumtoxinA

Primary outcomes

  1. Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)

    Time frame: From first dose of study drug up to 12 weeks post last dose (Up to 60 weeks)

    An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was an AE that occurred after receiving the first dose of investigational product or an AE present prior to first dose but increased in severity during the Treatment Period.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

BOTOX® Treatment in Pediatric Lower Limb Spasticity: Open-label Study

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
May 22, 2012
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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